Diffusion Pharmaceuticals Expands Patent Estate of TSC as Therapeutic in Five Hypoxia-Related Indications

Published on June 8, 2016

CHARLOTTESVILLE, Va., June 08, 2016 (GLOBE NEWSWIRE) — Diffusion Pharmaceuticals Inc. (OTCQX:DFFN), a clinical stage biotechnology company focused on the development of novel small molecule therapeutics for cancer, today announced that a U.S. patent application, entitled “Bipolar Trans Carotenoid Salts and Their Uses,” was allowed by the United States Patent and Trademark Office.

This application, which is expected to issue in the second half of 2016, expands coverage of the therapeutic use of trans sodium crocetinate (TSC) and other related compounds to five hypoxia-related conditions including congestive heart failure, chronic renal failure, acute lung injury (ALI), chronic obstructive pulmonary disease (COPD), and respiratory distress syndrome (RDS). Diffusion’s patent estate currently includes the use of TSC in oncology, stroke, and neurodegenerative disease (such as Alzheimer’s disease) indications.

David Kalergis, Chairman and Chief Executive Officer of Diffusion, remarked, “The allowance of this patent application is a significant milestone for Diffusion as it expands our patent estate and underscores the potential of TSC to serve as a primary therapeutic agent in many conditions involving hypoxia. Over the long term, we look forward to evaluating development opportunities across the five new indications covered by the patent. We are currently focused on expanding the clinical development pipeline for TSC from treatment for glioblastoma (GBM) to include treatment for pancreatic cancer.”

About Diffusion PharmaceuticalsDiffusion Pharmaceuticals is a clinical stage biotechnology company focused on extending the life expectancy of cancer patients by improving the effectiveness of current standard-of-care treatments including radiation therapy and chemotherapy. The Diffusion technology is a paradigm shift in the approach to the treatment of cancer and other diseases involving hypoxia, or oxygen deprivation, in that it facilitates the diffusion of oxygen to the hypoxic tissues. Diffusion is developing its lead drug, trans sodium crocetinate (TSC), for use in the many cancer types in which tumor hypoxia is known to diminish the effectiveness of current treatments. TSC targets the cancer’s hypoxic micro-environment, re-oxygenating treatment-resistant tissue and making the cancer cells more vulnerable to the therapeutic effects of treatments such as radiation therapy and chemotherapy, without the apparent addition of any serious side effects.

A Phase 2 clinical program, completed in the second quarter of 2015, evaluated 59 patients with newly diagnosed glioblastoma multiforme (GBM). This open label, historically controlled study demonstrated a favorable safety and efficacy profile for TSC combined with standard of care. The U.S. Food and Drug Administration has agreed upon the design of a Phase 3 trial in newly diagnosed GBM. Additional planned studies, subject to receipt of necessary financing, include the Phase 2 trial in pancreatic cancer and a study in brain metastases. Due to its novel mechanism of action, TSC has safely re-oxygenated a range of tumor types in our preclinical and clinical studies. The Company believes its therapeutic potential is not limited to specific tumors, thereby making it potentially useful to improve standard-of-care treatments of other life-threatening cancers.

Forward-Looking StatementsTo the extent any statements made in this news release deal with information that are not historical facts, these are forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about the company’s plans, objectives, expectations and intentions with respect to future operations and products, the potential of the company’s technology and product candidates, the continued development of TSC in GBM, pancreatic cancer and possibly other indications, and other statements that are not historical in nature, including those that utilize terminology such as “would,” “will,” “plans,” “possibility,” “potential,” “future,” “expects,” “anticipates,” “believes,” “intends,” “continue,” “estimates,” “targets,” “projects,” “intends,” and similar expressions, derivations of such words and the use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain and involve both known and unknown risks. These uncertainties and risks may cause the Company’s actual results to be materially different than those expressed in or implied by such forward-looking statements. Particular uncertainties and risks include: general business and economic conditions; the Company’s need for and ability to obtain additional financing; the Company’s ability to satisfy regulatory requirements with respect to its product candidates; the Company’s ability to maintain and defend its intellectual property; the conduct and success of the Company’s clinical trials, including successful enrollment in those trials; the safety and efficacy of the Company’s product candidates; the Company’s ability to retain and recruit qualified personnel; the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance; and the other factors discussed in the Company’s public filings, including the risk factors included in the Company’s most recent Annual Report on Form 10-K. All forward-looking statements in this news release speak only as of the date of this news release and are based on Company management’s current beliefs and expectations. Investors, potential investors and other readers are urged to consider these factors carefully in evaluating the forward-looking statements and are cautioned not to place undue reliance on such forward-looking statements. The Company undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise after the date of this release, except as required by applicable law.